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SERC 16MG TABLETS

Active substance(s): BETAHISTINE DIHYDROCHLORIDE

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S850 Leaflet Serc 20150604



PACKAGE LEAFLET: INFORMATION FOR USER

SERC 16mg TABLETS
(betahistine dihydrochloride)

Monoamine-oxidase inhibitors (MAOIs) – used to treat
depression or Parkinson’s disease. These may increase the
exposure of Serc.

Taking Serc with food and drink
You can take Serc with or without food.

Your medicine is known as Serc 16mg Tablets but will be referred
to as Serc throughout the following leaflet.
Information for another strength of Serc (Serc 8mg Tablets) also
may be present in this leaflet.
Read all of this leaflet carefully before you start taking this
medicine.


Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or
pharmacist.



This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



If any of the side effects becomes serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

Pregnancy and breast-feeding
Do not take Serc if you are pregnant unless your doctor has
decided that it is absolutely necessary. Ask your doctor for advice.
Do not breast-feed while using Serc unless instructed by your
doctor. It is not known if Serc passes into breast milk.
Driving and using machines
Serc is not likely to affect your ability to drive or use tools or
machinery. However, remember that diseases for which you are
being treated with Serc (vertigo, tinnitus and hearing loss
associated with Ménière’s syndrome) can make you feel dizzy or be
sick, and can affect your ability to drive or use machines.
3. HOW TO TAKE SERC

In this leaflet:

How to take Serc

1. What Serc is and what it is used for



Swallow the tablets with water.

2. Before you take Serc



Preferably take the tablet with a meal.

3. How to take Serc
4. Possible side effects

How much Serc to take

5. How to store Serc

Always follow your doctor’s instructions because your doctor might
adjust your dose

6. Further information



Serc is available in two strengths, an 8 mg tablet and a 16 mg
tablet.

1. WHAT SERC IS AND WHAT IT IS USED FOR



The usual starting dose is 16 mg three times a day (48 mg).

Serc contains betahistine. This medicine is called a histamine
analogue. It is used to treat:





dizziness (vertigo)



ringing in the ears (tinnitus)

 hearing loss suffered by people with Ménière’s disease
This medicine works by improving blood flow in the inner ear. This
lowers the build up of pressure.

Your doctor may lower your dose to 8 mg three times a day
(24 mg).
Keep taking your tablets. The tablets can take a while to start to
work.
Serc is not recommended for those under 18 years old.
How to stop taking Serc
Keep taking your tablets until your doctor tells you to stop.

2. BEFORE YOU TAKE SERC
Do not take Serc if:


You are allergic to any of the ingredients in the tablets (see
section 6 for further details).



You have high blood pressure due to an adrenal tumour
(phaeochromocytoma).
If any of the above applies to you, do not take this medicine and talk
to your doctor.

Even when you start feeling better, your doctor may want you to
carry on taking the tablets for some time to make sure that the
medicine has worked completely.
If you take more Serc than you should
If you or someone else takes too much Serc (an overdose), talk to a
doctor or go to a hospital straight away. Take the medicine pack
with you.
If you forget to take Serc

Take special care and tell your doctor if:


you have a stomach ulcer



you have asthma



you are pregnant or planning to become pregnant

 you are breast-feeding
If any of the above applies to you, talk to your doctor before taking
this medicine.
Your doctor will tell you whether it is safe for you to start taking this
medicine.
Your doctor may also want to monitor your asthma while you take
Serc.

If you miss a tablet, wait until the next dose is due. Do not try to
make up for the dose you have missed.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Serc can cause side effects (unwanted effects or
reactions), but not everyone gets them.
The following serious side effects may occur during treatment
with Serc:
Allergic reactions such as:


swelling of your face, lips, tongue or neck. This may cause
difficulty breathing.

Please tell your doctor or pharmacist if you are taking or have taken
any other medicines, including medicines obtained without a
prescription. This includes herbal medicines.



a red skin rash, inflamed itchy skin

In particular, tell your doctor or pharmacist if you are taking any of
the following medicines:

Common side effects (at least 1 in 100 and less than 1 in 10
patients):

Taking other medicines



Anti-histamines - these may (in theory) lower the effect of Serc.
Also, Serc may lower the effect of anti-histamines.

If any of these side effects occur you should stop treatment
immediately and contact your doctor.

Nausea, indigestion, headaches.

Other side effects

6. FURTHER INFORMAT ION

Itching, rash, hives, mild gastric complaints such as vomiting,
stomach pain and bloating. Taking Serc with food can help reduce
any stomach problems.

What Serc contains

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the United Kingdom national
reporting system The Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.



Each tablet contains 16mg of the active ingredient, betahistine
dihydrochloride,



Serc Tablets also contain the following inactive ingredients:
microcrystalline cellulose, mannitol, citric acid, colloidal
anhydrous silica and talc.

What Serc looks like and contents of the pack


By reporting side effects, you can help provide more information on
the safety of this medicine.

Serc Tablets are round, biconvex, white tablets marked ‘267’ on
either side of a scoreline on one side and plain on the reverse.



Serc Tablets are available as blister packs of 60 tablets.

5. HOW TO STORE SERC

Product Licence holder



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Procured from within the EU and repackaged by the PL holder:
S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA0 1DX.

Store in the original package to protect from light.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

Manufacturer
This product is manufactured by Abbott Healthcare SAS, Route de
Belleville – Lieu-dit Maillard, 01400 Chatillon sur Chalaronne,
France.
POM

PL 19488/0850

Leaflet revision date: 04 June 2015
Serc is a registered trade mark of Solvay Pharmaceuticals B.V.,
The Netherlands.
S850 Leaflet Serc 20150604

S850 Leaflet Betahistine 20150604

PACKAGE LEAFLET: INFORMATION FOR USER

BETAHISTINE DIHYDROCHLORIDE 16 mg TABLETS
Your medicine is known as Betahistine Dihydrochloride 16mg
Tablets but will be referred to as Betahistine Dihydrochloride
throughout the following leaflet.
Information for another strength of Betahistine Dihydrochloride
(Betahistine Dihydrochloride 8mg Tablets) also may be present in
this leaflet.
Read all of this leaflet carefully before you start taking this
medicine.


Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or
pharmacist.



This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



If any of the side effects becomes serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Betahistine Dihydrochloride is and what it is used for
2. Before you take Betahistine Dihydrochloride
3. How to take Betahistine Dihydrochloride
4. Possible side effects
5. How to store Betahistine Dihydrochloride
6. Further information
1. WHAT BETAHISTINE DIHYDROCHLORIDE IS AND WHAT IT
IS USED FOR
Betahistine Dihydrochloride contains betahistine. This medicine is
called a histamine analogue. It is used to treat:


dizziness (vertigo)



ringing in the ears (tinnitus)



hearing loss suffered by people with Ménière’s disease

This medicine works by improving blood flow in the inner ear. This
lowers the build up of pressure.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have taken
any other medicines, including medicines obtained without a
prescription. This includes herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of
the following medicines:


Anti-histamines - these may (in theory) lower the effect of
Betahistine Dihydrochloride. Also, Betahistine Dihydrochloride
may lower the effect of anti-histamines.



Monoamine-oxidase inhibitors (MAOIs) – used to treat
depression or Parkinson’s disease. These may increase the
exposure of Betahistine Dihydrochloride.

Taking Betahistine Dihydrochloride with food and drink
You can take Betahistine Dihydrochloride with or without food.
Pregnancy and breast-feeding
Do not take Betahistine Dihydrochloride if you are pregnant unless
your doctor has decided that it is absolutely necessary. Ask your
doctor for advice.
Do not breast-feed while using Betahistine Dihydrochloride unless
instructed by your doctor. It is not known if Betahistine
Dihydrochloride passes into breast milk.
Driving and using machines
Betahistine Dihydrochloride is not likely to affect your ability to drive
or use tools or machinery. However, remember that diseases for
which you are being treated with Betahistine Dihydrochloride
(vertigo, tinnitus and hearing loss associated with Ménière’s
syndrome) can make you feel dizzy or be sick, and can affect your
ability to drive or use machines.
3. HOW TO TAKE BETAHISTINE DIHYDROCHLORIDE
How to take Betahistine Dihydrochloride


Swallow the tablets with water.



Preferably take the tablet with a meal.

How much Betahistine Dihydrochloride to take
Always follow your doctor’s instructions because your doctor might
adjust your dose


Betahistine Dihydrochloride is available in two strengths, an 8
mg tablet and a 16 mg tablet.

Do not take Betahistine Dihydrochloride if:



The usual starting dose is 16 mg three times a day (48 mg).



You are allergic to any of the ingredients in the tablets (see
section 6 for further details).



Your doctor may lower your dose to 8 mg three times a day
(24 mg).



You have high blood pressure due to an adrenal tumour
(phaeochromocytoma).

Keep taking your tablets. The tablets can take a while to start to
work.

2. BEFORE YOU TAKE BETAHISTINE DIHYDROCHLORIDE

If any of the above applies to you, do not take this medicine and talk
to your doctor.

Betahistine Dihydrochloride is not recommended for those under 18
years old.

Take special care and tell your doctor if:

How to stop taking Betahistine Dihydrochloride



you have a stomach ulcer

Keep taking your tablets until your doctor tells you to stop.



you have asthma



you are pregnant or planning to become pregnant



Even when you start feeling better, your doctor may want you to
carry on taking the tablets for some time to make sure that the
medicine has worked completely.

you are breast-feeding

If any of the above applies to you, talk to your doctor before taking
this medicine.
Your doctor will tell you whether it is safe for you to start taking this
medicine.

If you take more Betahistine Dihydrochloride than you should
If you or someone else takes too much Betahistine Dihydrochloride
(an overdose), talk to a doctor or go to a hospital straight away.
Take the medicine pack with you.

Your doctor may also want to monitor your asthma while you take
Betahistine Dihydrochloride.
If you forget to take Betahistine Dihydrochloride
If you miss a tablet, wait until the next dose is due. Do not try to
make up for the dose you have missed.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMAT ION

Like all medicines, Betahistine Dihydrochloride can cause side
effects (unwanted effects or reactions), but not everyone gets them.
The following serious side effects may occur during treatment
with Betahistine Dihydrochloride:

What Betahistine Dihydrochloride contains


Each tablet contains 16mg of the active ingredient, betahistine
dihydrochloride,



Betahistine Dihydrochloride Tablets also contain the following
inactive ingredients: microcrystalline cellulose, mannitol, citric
acid, colloidal anhydrous silica and talc.

Allergic reactions such as:


swelling of your face, lips, tongue or neck. This may cause
difficulty breathing.



a red skin rash, inflamed itchy skin

If any of these side effects occur you should stop treatment
immediately and contact your doctor.

What Betahistine Dihydrochloride looks like and contents of
the pack


Betahistine Dihydrochloride Tablets are round, biconvex, white
tablets marked ‘267’ on either side of a scoreline on one side
and plain on the reverse.



Betahistine Dihydrochloride Tablets are available as blister
packs of 60 tablets.

Common side effects (at least 1 in 100 and less than 1 in 10
patients):
Nausea, indigestion, headaches.
Other side effects
Itching, rash, hives, mild gastric complaints such as vomiting,
stomach pain and bloating. Taking Betahistine Dihydrochloride with
food can help reduce any stomach problems.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the United Kingdom national
reporting system The Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on
the safety of this medicine.

Product Licence holder
Procured from within the EU and repackaged by the PL holder:
S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA0 1DX.
Manufacturer
This product is manufactured by Abbott Healthcare SAS, Route de
Belleville – Lieu-dit Maillard, 01400 Chatillon sur Chalaronne,
France.
POM

PL 19488/0850

Leaflet revision date: 04 June 2015
5. HOW TO STORE BETAHISTINE DIHYDROCHLORIDE


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Store in the original package to protect from light.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

S850 Leaflet Betahistine 20150604

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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